Objective: To observe the therapeutic effect and safety of modified Dunfutang in treatment of spleen-kidney Yang deficiency type ankylosing spondylitis (PSYXAS)

and investigate its possible mechanism. Method: A total of 209 PSYXAS patients were randomly divided into Chinese medicine group (69 cases)

western medicine group (67 cases) and integrated Chinese and western medicine group (73 cases). Patients in Chinese medicine group were treated with Dunfutang; patients in western medicine group were treated with diclofenac sodium sustained release tablets; and patients in integrated Chinese and western medicine group received Dunfutang and diclofenac sodium sustained release tablets

with a treatment course of 63 d in all groups.Then the spinal pain visual analogue scale (VAS) scores

bath ankylosing spondylitis metroloty index (BASMI)

bath ankylosing spondylitis functional index (BASFI)

patient global assessment (PGA)

and traditional Chinese medicine(TCM) spleen-kidney Yang deficiency syndrome scores were compared before and after treatment. The changes of C-reactive protein (CRP)

erythrocyte sedimentation rate (ESR)

tumor necrosis factor alpha (TNF-α) and platelet (PLT) were detected. Effective rate and incidence of adverse reactions were compared between various groups. Result: The total effective rate was 93.1% in integrated Chinese and western medicine group

significantly higher than 75.4% in Chinese medicine group and 71.6% in western medicine group (P<0.01). As compared with western medicine group

spleen-kidney Yang deficiency syndrome scores were improved more significantly in Chinese medicine group and the Chinese and western medicine group (P<0.05). For the other clinical symptom scores

the improvement in integrated Chinese and western medicine group was more obvious than that in Chinese medicine group and western medicine group (P<0.05) but with no significant difference between Chinese medicine group and western medicine group. The incidence of adverse reactions was as follows:Chinese medicine group (1.45%

1/69) < integrated Chinese and western medicine group (8.22%

6/73) < western medicine group (16.42%

11/67). Conclusion: Dunfutang and western medicine diclofenac lysine sustained release tablet have no significant difference in clinical efficacy for treatment of PSYXAS

and the incidence of adverse reactions of Dunfutang is lower than that of western medicine. In addition

Dunfutang combined with diclofenac lysine sustained release tablet has a better efficacy than diclofenac lysine sustained release tablet alone in the treatment of PSYXAS.